Qms Manager

About ViCentra

ViCentra is an innovative medical device company based in Utrecht, The Netherlands. ViCentra focuses on the research and development, manufacturing and commercialization of a ground-breaking device for the management of diabetes.

Kaleido, the smallest and lightest insulin pump system currently available, is designed to help people with diabetes live life on their own terms:

- "For us, super accurate insulin delivery and improved control are non-negotiables, but discretion, simplicity and choice is our way of helping you live life in your own way"._

Driven by ViCentra's desire to be meaningfully different, Kaleido aims to reduce the impact that diabetes can have on daily life. Utilizing Bluetooth wireless technology, Kaleido infuses colour and choice into the market, networking its hybrid patch pumps and handsets into a broader family of easy-to-use products and data services to create a customer-focused, integrated diabetes support service.

With CE mark, in-house software development and manufacturing, ViCentra is setting its sights on expanding insulin pump usage by appealing to both first time and experienced insulin pump users in the Netherlands. At the same time, we are preparing for FDA approval expansion into additional territories and establishing partnerships in digitalization and connectivity.

Funded by the venture capitalists LSP, INKEF, Invest-NL, Partners in Equity, and Health Innovations, ViCentra currently employs over 100 people from over 30 different nationalities.

The position

ViCentra is seeking a QMS Manager to join our vibrant organization. As QMS Manager you will report to the VP of Quality & Regulatory Affairs and your main responsibility is to ensure that the QMS implementation at ViCentra is suitable, adequate and effective and meets the requirements for the markets that the company serves. You will collaborate with key stakeholders to ensure all processes consistently meet established quality standards. You will also lead a culture of quality improvement through the creation and embedding of a quality mindset and the supporting framework to deliver business transformation and quality excellence.
- Main Responsibilities include but are not limited to:_
- Provide strategical direction for the ongoing development and improvement of the Quality Management System (QMS).
- Ensure alignment of QMS goals and objectives with company objectives and regulatory requirements.
- Lead efforts to ensure compliance with ISO 13485 standard for medical devices throughout all stages of the product lifecycle. - Ensure updates to the QMS are made as a result of changes in applicable regulations and standards.
- Ensure compliance of the QMS with the requirements in new markets
- Effective implementation of QMS, including, but not limited to Document Management, Change Management, Training, Internal Audits and CAPA - Facilitate management review meetings to assess QMS performance, identify areas for improvement, and drive strategic decisions.
- Provides Quality Data trend reports to Management and ensures appropriate recommendations for improvement actions and takes ownership for the follow-up of such actions - Evaluation, selection, planning and implementation of an Electronic Quality Management System (E-QMS) to streamline processes, enhance visibility, and improve QMS effectiveness.
- Education/Experience:_
- Bachelor’s degree.
- Experienced in similar function within a regulated industry, preferably medical devices
- Experienced with internal and external audits and inspections
- A comprehensive understanding of worldwide medical device quality regulations (ISO 13485, Regulation (EU) 2017/745 and 21 CFR 820). Knowledge of other Quality System Standards is a plus.
- Proven ability to work independently, hands-on and prioritize multiple projects simultaneously
- Able to manage multiple issues in a timeline driven environment.
- Skilled in leading and mentoring staff through influence rather than position power to achieve significant results
- fluency in English
- Desirable:_
- Previous experience working in a start-up/scale-up environment

What we offer

In addition to working on a ground-breaking new product, you’ll be working in a small, friendly and highly motivated team; all ideas are welcomed, and great work is rewarded. We’re also offering:

- A competitive salary
- 32 holiday days (pro rata) + 5 optional purchase days
- An average 40 hours per week (part-time staff are also welcome)
- Laptop and phone allowance
- Discount on gym membership
- Bike Scheme
- Informal dress code
- Free, on-site parking
- Multi-cultural working environment
- Social events and team lunches
- A work environment where you can develop your skills, learn from the best and be rewarded for your imagination.

If you've got any queries feel free to call +31 (0) 88 250 2900.